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Salary: USD 165,000 - 185,000 / annual
Artiva Biotherapeutics is a clinical-stage, publicly-traded biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases and cancers. The company's lead program, AlloNK®, is an allogeneic, off-the-shelf NK cell therapy currently being evaluated in three ongoing clinical trials for B-cell driven autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's disease. Artiva also has CAR-NK candidates targeting solid and hematologic cancers in development.
The Senior Clinical Trial Manager (Sr. CTM) will be responsible for oversight and execution of operational aspects of one or more clinical studies from protocol development through database lock. This role is part of the Clinical Operations team and involves managing external vendors and contract research organizations, preparing study documents per ICH GCP guidelines and Artiva SOPs, and coordinating study materials such as case report forms (CRFs), patient diaries, and source documents.
Key responsibilities include assisting with protocol development and Investigator Brochure updates, managing monitoring activities via contractors or CROs (including occasional on-site clinical monitoring), providing guidance to Clinical Research Associates, tracking patient enrollment and site qualification, reviewing key study quality metrics, coordinating study supplies and IP release packages, negotiating vendor contracts, reviewing informed consent forms and study materials, planning investigator meetings, supporting data query processes, ensuring regulatory compliance with FDA and ICH guidelines, and maintaining the trial master file.
The role requires approximately 25% travel, including occasional international travel. This is a senior individual contributor position with demonstrated responsibility for managing people in a matrixed environment and overseeing global clinical trials.
**Requirements:**
- BA/BS, nursing degree, or advanced degree (life sciences preferred)
- At least 7 years of experience in clinical trial management
- Experience in cell therapy, autoimmune disease, or rare disease (strongly preferred)
- Past management of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations
- Ability to work independently and in a team environment
- Proficiency with MS Office (Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills and strong organizational abilities
- Travel availability: approximately 25%, with occasional international travel
